Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
Observational Study to Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia, Myelodysplastic Syndrome and Myelproliferative Neoplasms
1 other identifier
observational
1,365
1 country
3
Brief Summary
The investigators are doing this research study to assess the percentage of patients receiving stem cell transplantation for the type of blood cancer you have. They want to know how many patients get a transplant and why some patients do get a transplant while others do not. Also they want to explore why some patients elect not to undergo stem cell transplantation, when it is recommended by their physicians.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2016
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 4, 2016
CompletedFirst Posted
Study publicly available on registry
February 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
January 20, 2026
January 1, 2026
11 years
February 4, 2016
January 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of patients who proceed to transplant
determine whether an individual patient proceeded to HCT when he or she was considered eligible (based on NCCN guidelines.
3 years
Study Arms (3)
Patients with Acute Leukemia (Arm A)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
Patients with MDS and MPN (Arm B)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
Patients with Acute Leukemia or MDS/MPN who Relapse After First Allografts (Arm C)
Follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
Interventions
All laboratory assessments performed on this study represent standard of care at our institution. HLA allele typing is performed by the center's HLA laboratory according to standard typing procedures.
Eligibility Criteria
Patients with acute leukemia and MDS or MPN who are treated inpatient or outpatient by the Leukemia Service for induction or re-induction therapy (acute leukemia) or initiation of therapy (for MDS or MPN) will be seen by the Adult BMT Service.
You may qualify if:
- Patients with newly diagnosed or relapsed acute leukemia. Patients undergoing reinduction due to primary induction failure are also eligible. Patients with acute leukemia will be enrolled to Arm A
- Patients with diagnosis of MDS, MPN and MDS/MPN overlap who meet any of the following criteria (based on NCCN guidelines):
- Clinically significant cytopenia of at least 2 cell lines affected; Hgb\<10,
- Platelet\<100,000, absolute neutrophil count\<1000
- Bone marrow blasts \>5% and any level of circulating blasts
- Evidence of disease progression or no response to hypomethylating agents/immunosuppressive treatment or a clinical trial.
- IPSS Intermediate-1 and higher
- IPSS-R intermediate and higher
- All cases of therapy related MDS with excess blasts
- In patients with Myelofibrosis: Low risk disease by DIPSS with either refractory, transfusion dependent anemia, circulating blasts cells greater than 2%; or adverse cytogenetics and any patient with DIPSS-intermidiate 1 and higher.
- Patients with acute leukemia or MDS/MPN who relapse after first allografts. Patients with post-transplant relapse will be enrolled to Arm C.
- Patients 18 years of age or older and 80 years of age or younger
- For the purposes of this protocol "relapse" is defined as re-emergence of the initial abnormal myeloid blast population (or blast equivalent) comprising 5% or more of marrow WBC or any amount prompting a therapeutic intervention targeting relapsed disease, including, but not limited to withdrawal of immunosuppression, targeted therapies, chemotherapy, etc.
You may not qualify if:
- Patients with polycythemia vera (PV) and essential thrombocytosis (ET)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roni Tamari, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2016
First Posted
February 9, 2016
Study Start
February 1, 2016
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
January 20, 2026
Record last verified: 2026-01